The PPQ of the manufacturing proces

The PPQ of the manufacturing process was successfully completed by producing four consecutive batches at the 12,000 L commercial manufacturing scale.The in-process test data, release test data and control of process parameters from the PPQ campaign demonstrated that the manufacturing process is controlled effectively and performs reproducibly to yield product that meets its pre-determined quality criteria.In addition, bioburden and bacterial endotoxin mapping, impurity clearance, process intermediate hold times as well as resin and membrane cleaning and lifetime study results are presented in support of the PV.The CPV stage of the PV will be initiated and will continue concurrently with commercial manufacturing.The final reporting of the process validation results is still ongoing and the relevant summaries are under preparation.